Browsing Tag
US Food and Drug Administration
348 posts
Allergan bags Ubrelvy FDA approval for migraine treatment
Ubrelvy FDA approval : Irish pharma company Allergan has bagged approval from the US Food and Drug Administration…
Micro Labs, Mylan secure FDA approval for first generics of Eliquis
Micro Labs and Mylan Pharmaceuticals have secured approval from the US Food and Drug Administration (FDA) for two…
FDA rejects Correvio Pharma’s anti-arrhythmic drug Brinavess
Correvio Pharma said that the US Food and Drug Administration (FDA) decided not to approve its anti-arrhythmic drug…
Amgen, Allergan file BLA to FDA for Rituxan biosimilar ABP 798
Rituxan biosimilar ABP 798 : US biopharma company Amgen and Irish pharma company Allergan have submitted a Biologics…
Astellas, Seattle Genetics bag Padcev FDA approval for advanced urothelial cancer
Padcev FDA approval : Astellas Pharma and Seattle Genetics have bagged accelerated approval from the US Food and…
Amarin bags Vascepa FDA approval for reducing cardiovascular risk
Vascepa FDA approval : New Jersey-based Amarin has secured approval from the US Food and Drug Administration (FDA)…
Incyte secures FDA priority review for pemigatinib in cholangiocarcinoma
Delaware-based pharma company Incyte has secured priority review for pemigatinib from the US Food and Drug Administration (FDA)…
Y-mAbs begins roll-out of BLA of naxitamab to FDA for neuroblastoma
US biopharma company Y-mAbs Therapeutics has submitted the first portions of its biologics license application (BLA) for naxitamab…
FDA approves ApiFix MID-C system for progressive AIS
Israeli medical devices manufacturer ApiFix has bagged approval from the US Food and Drug Administration (FDA) for marketing…
FDA clears Biobeat wearable watch and patch for BP measurement
Israeli biotech company Biobeat has secured a 510A clearance from the US Food and Drug Administration (FDA) for…